投诉管理是药品生产企业质量保证系统的核心要素之一，在药品生产实践和监督检查中，投诉管理环节仍暴露出一系列突出问题。梳理国内外GMP关于投诉管理的法规要求和核心要点，并结合近年来药品检查中发现的约60项投诉管理缺陷，将其归纳为投诉管理程序和计划缺陷、投诉管理人员和组织缺陷、投诉调查和处理过程缺陷、投诉记录和台账缺陷、投诉结果和纠正预防措施联动缺陷5个方面的典型问题，以期为企业提升投诉管理有效性、完善质量管理体系提供参考。

Complaint management is one of the core elements of the quality assurance system in pharmaceutical production enterprises. In the practice and supervision of drug production, a series of prominent problems are still exposed in the complaint management process. This article summarizes the regulatory requirements and core points of GMP on complaint management at home and abroad, and combines about 60 complaint management deficiencies discovered in drug inspections in recent years to summarize them into five typical problems: defects in complaint management procedures and plans, defects in complaint management personnel and organizations, defects in complaint investigation and handling processes, defects in complaint records and ledgers, and defects in the linkage between complaint results and corrective and preventive measures. The aim is to provide reference for enterprises to improve the effectiveness of complaint management and perfect their quality management system.

R951